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Results For "GEA"

182 News Found

NMPA approves CStone's NDA for Cejemly
Drug Approval | December 21, 2021

NMPA approves CStone's NDA for Cejemly

The NMPA approval is based on the positive data of GEMSTONE-302 study, a multi-center, randomized, double-blind, phase III study that evaluated the efficacy and safety of Cejemly or placebo in combination with chemotherapy in first-line stage IV NSCLC patients


Merck’s tepmetko receives positive CHMP opinion in Europe
Biotech | December 20, 2021

Merck’s tepmetko receives positive CHMP opinion in Europe

The medicine is the first and only oral MET inhibitor to receive CHMP positive opinion in Europe for adult patients with advanced NSCLC harbouring alterations leading to METex14 skipping


Immatics and Bristol Myers Squibb enter exclusive license for TCR Bispecific programme
Biotech | December 15, 2021

Immatics and Bristol Myers Squibb enter exclusive license for TCR Bispecific programme

Immatics to receive upfront payment of US $ 150 million and additional milestone payments of up to US $ 770 million plus tiered double-digit royalties on net product sales


Roche to launch SARS-CoV-2 and flu A/B Rapid Antigen Test in countries accepting the CE mark
Medical Device | December 06, 2021

Roche to launch SARS-CoV-2 and flu A/B Rapid Antigen Test in countries accepting the CE mark

The combination rapid antigen test quickly differentiates between SARS-CoV-2 and influenza viruses A and B infections, with results ready in less than 30 minutes, allowing informed decisions on patient and pandemic management decisions


Pharma firms switch to advanced pharma manufacturing
Supply Chain | November 27, 2021

Pharma firms switch to advanced pharma manufacturing

Market demand for significant volumes and quality of biopharma products would drive continuous manufacturing technologies


Aadi Bioscience secures U.S FDA approval of its first product Fyarro
Drug Approval | November 26, 2021

Aadi Bioscience secures U.S FDA approval of its first product Fyarro

Fyarro is the first and only approved therapy for adults for the treatment of malignant PEComa in adults


Merck showcases potential for several cancers, MS and lupus
News | November 22, 2021

Merck showcases potential for several cancers, MS and lupus

Five potential first-in-class assets aimed at delivering significant long-term growth. Over 14 clinical development programs underway across portfolio and 11 new studies to start in 2022 across early- and late-stage pipeline


Biocon Biologics and Viatris announce US launch of Semglee
News | November 17, 2021

Biocon Biologics and Viatris announce US launch of Semglee

Branded and unbranded versions of the first-ever interchangeable biosimilar in the U.S. provide more affordable options for the millions of Americans living with diabetes


Meridian Bioscience receives U.S. FDA Emergency Use Authorization for Revogene SARS-CoV-2 molecular assay
Biotech | November 12, 2021

Meridian Bioscience receives U.S. FDA Emergency Use Authorization for Revogene SARS-CoV-2 molecular assay

The company expects to begin shipping this product before the end of its fiscal first quarter, ending December 31, 2021


Sun Pharma to introduce molnupiravir in India
Drug Approval | November 12, 2021

Sun Pharma to introduce molnupiravir in India

The Drug Controller General of India (DCGI), is reviewing clinical data of molnupiravir for the treatment of Covid-19 in adults in India